Artis Pheno — Class II medical device recall Z-1294-2022
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2022-07-06, distributed nationwide. A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transce
| Recall number | Z-1294-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2022-06-10 |
| Classified | 2022-06-27 |
| Reported by FDA | 2022-07-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, CN, CO, DE, DK, ES, FI, FR, GB, HU, ID, IR, IT, JP, KW, MX, NL, NO, PL, SE, SG, SK, TH, TR, TW, VN, ZA |
| Quantity | 136 systems |
| UPC / GTIN / UDI-DI | 04056869046877 |
| Serial numbers | 164011, 164013, 164018, 164019, 164021, 164022, 164024, 164025, 164026, 164027, 164028, 164033, 164034, 164048, 164049, 164053, 164054, 164055, 164057, 164060, 164061, 164063, 164064, 164066, 164068 and 111 more |
| Model numbers | 10849000 |
Product
Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
Reason for recall
A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This issue can sporadically affect the Large Display in the examination room as well as the displays in the control room.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1294-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.